Probiotics for preterm infants and the recent FDA alert in the USA

Embleton, Nicholas D., Berrington, Janet, Clarke, Paul ORCID: https://orcid.org/0000-0001-6203-7632, Deierl, Aniko, Luyt, Karen, Spruce, Marie and Oddie, Sam J. (2023) Probiotics for preterm infants and the recent FDA alert in the USA. Archives of Disease in Childhood - Fetal and Neonatal Edition. ISSN 1359-2998

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Abstract

The US Food and Drug Administration (FDA) recently issued a warning regarding probiotic use in preterm infants1 leading to the withdrawal of at least two products in the USA. Product withdrawal may extend to Europe, if companies become unwilling to risk legal challenges for products that may not generate significant profits. The FDA alert highlighted the risk of € invasive, potentially fatal' sepsis with probiotics, and the unregulated nature of the market. Product marketing may have implied probiotics reduce necrotising enterocolitis (NEC), when such a claim can only be made with high-quality randomised controlled trial (RCT) evidence. Despite a plethora of RCTs and meta-analyses (MAs), no RCT with NEC as a primary outcome has shown benefit, nor has any RCT been powered with NEC as the primary outcome. This is disappointing as NEC is responsible for more than 1:20 child deaths before age 10 years.2 Nevertheless, most neonatal medicine practice is based on MAs, observational studies and clinician experience rather than definitive RCTs.

Item Type: Article
Uncontrolled Keywords: gastroenterology,intensive care units, neonatal,microbiology,sepsis,therapeutics,pediatrics, perinatology, and child health,obstetrics and gynaecology ,/dk/atira/pure/subjectarea/asjc/2700/2735
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
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Depositing User: LivePure Connector
Date Deposited: 20 Dec 2023 02:57
Last Modified: 03 Jan 2024 03:18
URI: https://ueaeprints.uea.ac.uk/id/eprint/94014
DOI: 10.1136/archdischild-2023-326580

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